Thursday, March 28, 2013

Yesterday, a Huff Post Livesegment focused on electronic cigarettes, especially the issue of whether their use should be banned in public places. Cynthia Hallett of Americans for Nonsmokers' Rights and Dr. David Abrams of Legacy argued that we just don't know enough about what is in electronic cigarette vapor and so we shouldn't allow their use in public places. I argued that we actually have a very good idea of the components of e-cigarette vapor and that there just is not evidence to support the contention that this is a serious public health issue that warrants banning vaping in public.

Wednesday, March 27, 2013

In 2013, even the tobacco companies have acknowledged for more than a decade that cigarette use is very hazardous to health and refrain from minimizing the risks of smoking by comparing it to clearly less hazardous activities such as using non-tobacco products.

Not so for one of the leading national anti-smoking organizations: the American Legacy Foundation.

In its apparent zeal to squelch the phenomenon of smokers using something that looks like a cigarette to potentially save their lives, the American Legacy Foundation is telling smokers, and the public, that there is no evidence that cigarette smoking is any more hazardous than vaping, which involves the use of a product that contains no tobacco.

Even the tobacco companies themselves would not dare make such a bald claim in 2013 - that cigarettes may be no more hazardous than the use of a non-tobacco product.

"Electronic cigarettes are designed to give you an experience that’s like
smoking but without any smoke. Since they don’t burn tobacco, they’re
marketed as less harmful than regular cigarettes. But so far, there’s no
evidence to prove that claim. There’s also no evidence that electronic
cigarettes help you quit smoking."

The Rest of the Story

There are actually two false statements in the American Legacy Foundation's "fact" sheet about electronic cigarettes.

First, Legacy is misleading the public by suggesting that there is no evidence that
smoking is any more harmful than vaping. This is a dangerous and misleading statement. Legacy is implying that smoking is not
all that hazardous, since if it is no worse than electronic cigarette
use, it involves only exposure to minute levels of carcinogens (as has
been documented to be the case with electronic cigarettes).

It doesn't take a rocket toxicologist to figure out that the current
data on the levels of carcinogens in cigarettes versus electronic
cigarettes does provide strong evidence that vaping is less hazardous
than smoking, and specifically, that vaping is associated with a lower cancer and chronic lung disease risk than active smoking of cigarettes that combust tobacco.

In
fact, I have estimated that the level of tobacco-specific nitrosamines
in electronic cigarettes is about 1400 times lower than that in
Marlboros. In light of these data, how can Legacy possibly argue that there
is no evidence that smoking Marlboros is any more dangerous than using
an electronic cigarette?

It is problematic enough to disseminate
irresponsible advice to the public about such an important a health
issue as quitting smoking. But to base that advice on blatant
misrepresentations of the available scientific data to the public is
even worse.

Why is Legacy ignoring the available data
which clearly show that the levels of carcinogens in electronic
cigarettes are orders of magnitude lower than in regular cigarettes?

Frankly, this isn't science anymore. It's becoming pure propaganda.

Unfortunately,
there appears to be a very strong bias operating which does not allow
anti-smoking groups - like Legacy - to objectively view the scientific evidence on
electronic cigarettes. I believe that the very fact that these devices
are similar to cigarettes blinds many anti-smoking groups to the
actual scientific evidence that is readily available. It is apparently
not the documented hazards of vaping which are troubling the
anti-smoking movement, but the fact that it looks like smoking. How
can anything which looks like smoking be a good thing, even if there is
strong evidence that these products are bringing immense and immediate
health benefits to thousands of users?

According to the American Legacy Foundation, smokers who have quit smoking
successfully using electronic cigarettes may just as well return to
their Marlboros than remaining ex-smokers with the use of electronic
cigarettes because there is no evidence to prove that they have lowered their health risks by quitting smoking and using non-tobacco electronic cigarettes instead. Any physician who gave that medical advice would be doing a great
disservice to his or her patients. What the American Legacy Foundation is
doing, then, is committing public health malpractice on a massive
scale.

Legacy makes a second false statement by asserting that there is "no" evidence that electronic cigarettes can help people quit smoking. There is actually subtantial evidence, coming both from the testimonials of thousands of electronic cigarette users who have reported successfully quitting using these products and from a clinical trial demonstrating that even among smokers with no desire to quit, electronic cigarettes helped more than half of them to achieve smoking cessation or smoking reduction.

In light of the existing evidence, how can one Legacy deceive the public by asserting that there is no evidence
for the potential of electronic cigarettes in smoking cessation. To do
so is to completely ignore the results of the clinical trial evidence,
as well as to ignore the multitude of anecdotal evidence based on
personal reports of ex-smokers.

Moreover, the advice from the American Legacy Foundation is
irresponsible because it suggests that the many electronic cigarette
users who have quit successfully using these devices should discontinue
their use and take their chances with NRT or Chantix. But because a
large proportion of these ex-smokers are vaping specifically because
they tried NRT or Chantix and failed, this advice is tantamount to
urging these ex-smokers to return to cigarette smoking. It is difficult
to imagine more irresponsible medical advice.

In fact, many vapers have reported dramatic improvement in their health,
such as increases in lung function and physical stamina. Discontinuing
electronic cigarette use and returning to smoking is the last thing in
the world these individuals should be encouraged to do. Returning to
smoking will undoubtedly harm the health of these individuals and
perhaps even ruin what would have been a great opportunity to keep them
off cigarettes permanently.

Making Legacy's statement even more problematic is the fact that it fails to disclose anywhere on the web page that it has a financial conflict of interest in recommending NRT and Chantix while shunning electronic cigarettes by virtue of its having received funding from pharmaceutical companies that manufacture the former products.

As I revealed last week, the American Legacy Foundation has received substantial funding from
Pfizer - the very company which manufactures Chantix, a smoking
cessation drug which stands to lose severely if electronic cigarettes
become more and more popular. Thus, the Foundation's receipt of funding
from Pfizer is a conflict of interest that I believe should have been
revealed in its statement providing medical advice to smokers, urging
them to use a drug like Chantix rather than to try electronic
cigarettes.

The rest of the story is that the American Legacy Foundation is doing something that even the tobacco companies would not dare: claiming that there is no evidence that cigarette smoking is more hazardous than using a non-tobacco, non-combustion product that has been shown to contain levels of carcinogens that are up to 1400 times lower than in cigarettes.

Of course I applaud Legacy's efforts to support smoking cessation among smokers and fully support the Foundation in those efforts. But it is also important to be truthful and to maintain a high level of scientific integrity. And it undermines the very purpose of the Foundation when it discourages literally millions of smokers from attempting to quit using a strategy that has been successful for thousands of (now) ex-smokers. We can certainly have differences of opinion about the appropriate role of electronic cigarettes in a national smoking cessation strategy, but if we can't even get past arguing that there's no evidence smoking is any more hazardous than vaping, then there's no possibility of having any kind of evidence-based discussion. We're left in the land of ideology and propaganda, not science.

Tuesday, March 26, 2013

NJOY - a leading electronic cigarette company - has announced that former Surgeon General Dr. Richard Carmona has joined its Board of Directors and will serve as chair of its Scientific Advisory Board. Dr. Carmona served as Surgeon General from 2002-2006, a period during which he released a landmark report on the health effects of secondhand smoke.

According to the company's press release: "“Dr. Carmona is an important addition to NJOY’s Board and we are pleased
that he has agreed to serve in this valuable role for our company,” said
Craig Weiss, Chief Executive Officer of NJOY. “His expertise will be
critical as we look to enhance our efforts to ensure cohesive and
effective regulation in the category and raise awareness about
e-cigarettes as a viable alternative for adult tobacco consumers. At
NJOY, we are proud to be a leader in this process and believe our
products have the potential to render traditional cigarettes obsolete.”

“NJOY is a clear and responsible leader in the growing and important
electronic cigarette industry and I have been impressed with their
commitment to science. They have a clear vision of the importance that
ongoing scientific dialogue and research will play in shaping the
regulatory and public health landscape today and in the future,” said
Dr. Carmona. “I believe that it is essential that we provide adult
smokers with high-quality, innovative alternatives to traditional
cigarettes. The current data indicate that electronic cigarettes may
have a very meaningful harm reduction potential, and NJOY is committed
to the further development of the science in this area. I look forward
to working with NJOY in this important capacity.”"

The Rest of the Story

This is an important story because it represents one of the first "mainstream" anti-smoking advocates endorsing electronic cigarettes as a viable harm reduction strategy in tobacco control. It immediately gives electronic cigarettes increased credibility and respect as a strategy for smoking cessation and forces anti-smoking groups, researchers, and the FDA to take these products seriously as a meaningful new strategy to reduce tobacco use.

As NJOY has made clear, electronic cigarette companies are committed to the ultimate goal of rendering "traditional cigarettes obsolete." By definition, the very purpose of these products is to attract smokers away from using cigarettes. This basic point is still misunderstood by many anti-smoking advocates, groups, and researchers.

Hopefully, the appointment of Dr. Carmona to the Board of NJOY will help wake up the tobacco control movement and force it to re-think its ideological opposition to a strategy that has a great potential to save lives and reduce disease.

Monday, March 25, 2013

A study published online in the journal PLoS ONE concludes that a partial smoking ban in Prince Edward Island resulted in a 14%-24% decline in heart attack admissions, while the study data show that the rate of heart attacks actually increased in the five-year period following the smoking ban compared to the five-year period before the ban.

A partial smoking ban went into effect in Prince Edward Island on June 1, 2003. Smoking was banned in all public places and workplaces, but was still allowed in designated smoking rooms. The study compares the rate of heart attack admissions before and after the smoking ban.

It finds that: "The mean rate of acute myocardial infarctions was reduced by 5.92
cases per 100,000 person-months (P = 0.04) immediately after the smoking
ban."

The study conclusion is based entirely on the abnormally low heart attack rates observed during the period 1995-1997. If one compares the trend in heart attacks from 1998-2003 (five years prior to the smoking ban) with the trend from 2003-2008 (five years after the smoking ban), one finds that the smoking ban was actually associated with an increase in the rate of heart attacks.

Here are the approximate trends in the heart attack rates in the five-year periods before and after the smoking ban:

1998-2003 (PRIOR TO BAN): -0.4% per year
2003-2008 (AFTER BAN): +1.1% per year

Thus, prior to the smoking ban, the heart attack rate was quite steady, declining slightly by about 0.4% per year. Following the ban, the heart attack rate increased by 1.1% per year.

These findings are hardly indicative of a significant and substantial (14%-24%) reducing in the heart attack rate that is attributable to the smoking ban. In fact, an examination of the data indicates that the finding reported in the paper is not at all robust and neither the data nor the analysis supports the study's conclusion.

In fact, the authors could just have easily compared the five-year periods before and after the smoking ban and concluded that the ban led to an increase in hospitalizations for acute myocardial infarction.

Incidentally, I would not have expected this policy to reduce heart attacks because it did not eliminate smoking, it restricted it to designated smoking rooms. But whether expected or not, the data simply do not support the study's conclusion that this partial smoking ban resulted in a significant and substantial decline in heart attack admissions.

At this point, it has become clear to me that there exists a strong investigator bias in favor of finding a significant effect of smoking bans on the reduction of heart attacks. So many studies have drawn conclusions that are simply not supported by the data that it is apparent that investigators want to find an effect.

I "want" there to be an effect as well, since I've devoted much of my career to promoting workplace smoking bans. But we have to remain objective and use rigorous scientific methods. In the long run, I don't think it serves us to lower the level of scientific analysis in order to be able to put out "favorable" findings. After all, our scientific integrity and the public's trust of the quality of our science are the foundation upon which pu.blic health is built.

Friday, March 22, 2013

In a public statement of February 28, the American Legacy Foundation has this medical advice for smokers who are considering quitting using electronic cigarettes: Don't. Instead, use nicotine replacement therapy (NRT) or Chantix.

According to the statement: "Given the poor quality control of these products, consumers are taking
unknown risks by using e-cigarettes, with few proven benefits. Until
adequate research and regulation is in place, users should be wary of
using e-cigarettes, and smokers who want to quit should pursue
science-based effective cessation tools, such as nicotine replacement
products, free counseling services available via telephone quit lines
and Web-based cessation services, as well as non-nicotine
pharmacotherapies."

One of these "non-nicotine pharmacotherapies" is of course Chantix, which has been associated with hundreds of deaths from suicide or other severe forms of violence. The number of lawsuits against Pfizer for deaths or severe injuries allegedly due to Chantix use exceeds 3,000.

Despite these severe adverse effects that have been associated with the use of Chantix, the American Legacy Foundation fails to give these effects so much as a mention in its statement.

While Legacy avoids making any mention of the known risks of Chantix, it does emphasize the unknown risks of electronic cigarettes, which the Foundation cannot articulate because so far, none have been clearly identified or documented.

While it is problematic that Legacy is presenting a biased picture of the health information regarding the known risks of various drugs used for smoking cessation by recommending Chantix - which has been associated with hundreds of deaths - while discouraging the use of electronic cigarettes - which have yet to be associated with a single death, that is not what this post is about.

The Rest of the Story

This post is about the ethical obligation of a body giving medical advice to the public about the use of various drugs to disclose any financial conflicts of interest related to funding received from makers of those drugs. It is because of the failure of the American Legacy Foundation to disclose its conflicts of interest with the very maker of the drug it is recommending for smokers over e-cigarettes (despite the vast difference in the currently known safety profiles of the two drugs) that I am writing.

The American Legacy Foundation has received substantial funding from Pfizer - the very company which manufactures Chantix, a smoking
cessation drug which stands to lose severely if electronic cigarettes
become more and more popular. Thus, the Foundation's receipt of funding
from Pfizer is a conflict of interest that I believe should have been
revealed in its statement providing medical advice to smokers, urging them to use a drug like Chantix rather than to try electronic cigarettes.

What is the evidence for a financial connection between Pfizer and the
American Legacy Foundation? Although you apparently won't easily find any
disclosure of this connection on the Legacy web site, Pfizer - unlike Legacy - is
transparent, and readily reports its donations to the American Legacy
Foundation on its web site:

Pfizer is not the only pharmaceutical company from which Legacy has taken money. The Foundation also admits to receiving funding from GlaxoSmithKline, Novartis Consumer Health, and Schering-Plough between 2008 and 2010.

The rest of the story is that these substantial conflicts of interest
were not revealed in the statement of medical advice to smokers, thus hiding from smokers the fact that
this advice could potentially be affected by, influenced by, or biased due to the funding from multiple companies that manufacture smoking cessation drugs
and stand to lose tremendously if electronic cigarettes become more
popular. I think that smokers deserve to have this information and I
therefore think these conflicts should have been disclosed.

Furthermore, I think that relevant financial conflicts of interest among Legacy senior staff members should also have been disclosed. Thus, the statement should have revealed that Dr. David Abrams - a Legacy senior staff member - has received grant funding from multiple pharmaceutical companies
that have investigated or manufactured smoking cessation drugs,
including Eli Lilly, Dupont Merck, Glaxo-Wellcome, SmithKline Beecham,
Sano Corporation, Bristol-Myers Squibb, Knoll Pharmaceuticals, and
Pfizer.

Lack of transparency in failing to disclose financial conflicts of interest has become a serious problem in tobacco control, but it is a particularly substantial problem when it involves a statement providing medical advice to smokers in which the financial relationships of the body making the statement and the drug companies making the recommended products are not disclosed.

Thursday, March 21, 2013

According to a version of the proposed ordinance provided by the Wall Street Journal, Mayor Bloomberg's proposal that I discussed yesterday would ban the display of cigarettes or tobacco products in retail stores, but not advertisements or promotions for these products.

The proposed ordinance states: "A retail dealer shall not display or permit the display of any cigarettes or cigarette packaging in a manner that allows a person to view such cigarettes or cigarette packaging prior to purchase at any place of business operated by such dealer."

The same clause is then repeated with respect to tobacco products.

The Rest of the Story

If this version of the proposed legislation is correct and complete, then it does not take any action to regulate the advertising or promotion of cigarettes or tobacco products. Instead, it merely regulates the display of these products, mandating that they be kept out of public view.

But this means that a store could have a huge promotional ad or display for cigarettes, as long as actual cigarette packs were not part of that display.

This seems to undermine the entire purpose of the ordinance.

Tobacco companies could even use this proposed law to their advantage: Imagine a huge promotional display with a picture of a desert island and a message that states: "Discover life's hidden pleasures...Ask where Capri cigarettes are hiding."

Or a promotional display with a beautiful Wyoming mountain scene with the question: "Where is Marlboro Country? Ask your store clerk to help you find your special spot for freedom."

Sadly, but not surprisingly, it appears that the anti-smoking groups supporting this proposal didn't think it through. And they don't even appear to understand it, or to have actually read the text.

The Campaign for Tobacco-Free Kids issued a knee-jerk press release praising the measure but went on to misconstrue the proposal, stating that the law will: "prohibit massive store displays of tobacco products that tell kids
tobacco use is normal and acceptable, while tempting smokers trying to
quit into buying more cigarettes." This is deceptive, as the proposal would prohibit such displays only if they included the tobacco products themselves. A beautiful and elaborate display that advertises and promotes cigarettes, tells kids that tobacco use is normal and acceptable, and tempts smokers trying to quit into buying more cigarettes is still perfectly fine under this proposal.

If the Mayor and the Campaign for Tobacco-Free Kids are so concerned about youth smoking that they cannot even fathom the idea of a youth seeing a cigarette pack, then perhaps they should put their money where their mouth is and simply ban the sale of cigarettes in the city. Right now, they are just blowing smoke and playing politics. No one is going to stop or avoid smoking because of this proposal. The only benefit is a political one. And I think it's time to start putting kids and their health ahead of political games.

Wednesday, March 20, 2013

According to a CNN article, Mayor Michael Bloomberg has proposed a law that would require retail stores in New York City that sell tobacco to keep these products hidden; that is, out of sight of customers.

According to the article: "After naming tall sugary
drinks Public Enemy No. 1, New York Mayor Michael Bloomberg on Monday
unveiled another public health initiative. This one would force city
retailers to keep tobacco products out of sight. But does out of sight necessarily mean out of mind? "Young people are targets
of marketing and the availability of cigarettes," said the mayor. The
legislation "will help prevent another generation from the ill health
and shorter life expectancy that comes with smoking." ... Under the Tobacco
Product Display Restriction bill, sellers would have to keep tobacco
products hidden, in cabinets, under the counter or behind a curtain,
except during a purchase by an adult or during restocking. If it passes, New York would become the nation's first city to enact such a law, Bloomberg said. The mayor said the city is trying to dissuade customers from viewing cigarettes as 'normal.'"

The Rest of the Story

If tobacco products are kept hidden, then the question naturally arises: how would customers find the cigarettes?

There are a number of possibilities.

First, customers could be provided with a sort of treasure hunt, with a series of clues that eventually lead to the hidden location. The beauty of this model is that the clue cards could each contain a graphic warning label showing smoking's health effects, thus nullifying the effect of the court decision which overturned placing such labels on the pack itself. In order to find the pack, the potential customer would have to make her way through dozens of clues, each with its own graphic warning. Most customers would have trouble making it past the 3rd or 4th clue card.

A second possibility is that customers could be provided with basic orienteering equipment, including a map and compass. Using directional cues and with proper use of the equipment, the customer would gradually hone in on the precise location of the desired merchandise, assuming that climate conditions are favorable and unexpected wind, high ventilation, and magnetic interference are kept to a minimum.

A third possibility involves a version of the game "20 Questions." The customer would have 20 questions to ask the retail clerk, within which he would have to figure out the location of the merchandise. The hitch, of course, is that only "yes" and "no" questions could be asked.

Then there is the Lifeline version of in-store retail tobacco product seeking. The customer can either be given two options where the cigarettes are (one correct and one incorrect), be allowed to phone a friend, or be allowed to poll the customers inside the store. The North Atlantic Convenience Store Association is apparently strongly against this proposal, as it would be costly to equip convenience stores with the necessary audience response technology.

A fifth possibility is that the cigarettes could be kept in special boxes that are only visible with the specialty 3-D Viewing Glass system. Only customers ages 21 and older would be provided with these special glasses.

Finally, there is the old fashioned "Hide and Seek" free-for-all. This possibility has inventory and floor managers jittery. To help keep things under control, customers would only be allowed to seek during the "Green Light" condition. When "Red Light" is called, customers would have to freeze. Any customer caught moving would be sent back to the beginning.

Monday, March 18, 2013

In their weekly report for March 7, tobacco analysts at Morgan Stanley research noted approximately a 4.5% decline in cigarette sales compared to that expected in 2013 (see: Adelman DJ, Grainger M, Ayala V, Paxton K. Tobacco: New Years' Resolutions + E-Cigs = Weaker Volumes? New York: Morgan Stanley Research North America, March 7, 2013).

Readers should note that a 4.5% decline in cigarette consumption is a substantial public health accomplishment. Here is a question for my readers: Which of the following was given as the leading explanation for the public health advances of early 2013?

a. A massive anti-smoking advertising campaign by the FDA which penetrated deeply into all major national media;
b. A national effort to promote smoke-free workplaces in all states and cities that have not yet enacted such laws;
c. A national effort to urge states to increase their cigarette taxes and allocate the revenue to anti-smoking programs; or
d. The tremendous growth of electronic cigarettes.

The answer - according to the Morgan Stanley tobacco team - is D: The tremendous growth of electronic cigarettes.

The Rest of the Story

The rest of the story is that the greatest public health accomplishment of 2013 in terms of saving lives from smoking-related diseases has come not from any action of the FDA or national anti-smoking groups, but from the natural growth of a product which all of these groups wanted banned from the market. In other words, major public health advances in tobacco control have come not because of the FDA and national anti-smoking agenda, but in spite of it.

So here is another question for my readers:

Which of the following represents the greatest threat to saving lives from smoking-related disease by drastically reducing cigarette consumption?

a. the failure of electronic cigarettes to continually improve their performance and distribution;
b. the general lack of content of electronic cigarette customers with these products;
c. increasing evidence of the health hazards of electronic cigarettes;
d. increasing evidence that e-cigs have dismal effectiveness in smoking reduction;
e. the efforts of the FDA and national anti-smoking groups to get e-cigs off the market or make it virtually impossible to market them effectively.

The answer is: E: the efforts of the FDA and national anti-smoking groups to get e-cigs
off the market or make it virtually impossible to market them
effectively.

It is ironic that the FDA is seen as the main obstacle to the massive decline in cigarette consumption that is predicted to occur due to electronic cigarettes. If the FDA and anti-smoking groups were interfering with any other intervention that showed as great promise in reducing cigarette consumption, you can imagine that the public would be outraged.

Well, perhaps the public should be outraged because this is precisely what is happening. While there still is an escape hatch for the FDA (carving out a separate regulatory framework for electronic cigarettes that enhances the ability of companies to make reduced exposure, reduced risk, and smoking cessation or reduction claims), I have heard no discussion to indicate that this is the direction that the agency is likely to go.

My five key points related to potential FDA reglation of tobacco products are included in a special Tobacco Journal Internationalfeature on electronic cigarettes.

NOTE: Thanks to David Sweanor, who provided ideas for much of the intellectual content of this commentary.

Thursday, March 14, 2013

Last year, New York City Mayor Michael Bloomberg proposed, and the Department of Health and Mental Hygiene adopted, a city regulation that banned the sale of soda and other sugar-laden
drinks in sizes of more than 16 ounces in New York restaurants, food
carts, and movie theaters. The proposal, which was slated to go into effect this week, would not have affected the sale of
milk shakes and would not have regulated the sizes of soft drinks sold in grocery stores, convenience stores, gas stations, and other
stores that are not considered "restaurants."

"Think this proposal would mark the end of Slurpies and Big Gulps from
Seven Eleven and similar monster soda and sugar drinks from other
convenience stores?"

"The answer is no. And that goes to show the pointlessness of the
proposal. The regulation is so limited that it will have no effect on
the public's health. Why ban the sale of monster sodas only in
restaurants? What good is a restaurant monster soda ban if people can
still walk into a Seven Eleven and purchase a 64-ounce Double Big Gulp?
How often do people go to the movies such that banning the sale of
monster sodas in theaters is going to combat the city's obesity
epidemic? What sense is there to ban monster sodas in delis if in those
same restaurants, a person can order a humongous milk shake?"

On Tuesday, Justice Milton Tingling of the Supreme Court of the State of New York in Manhattan asked the same questions in invalidating the regulation.

The two key points of his decision, both being necessary to invalidate the regulation, were:

(1) "This court finds that the regulation herein is laden with exceptions based on economic and political concerns."

(2) "The Rule is nevertheless fraught with arbitrary and capricious consequences. The simple reading of the Rule leads to the earlier acknowledged uneven enforcement even within a particular City block, much less the City as a whole. Furthermore, as previously discussed, the loopholes in this Rule effectively defeat the stated purpose of the Rule. It is arbitrary and capricious because it applies to some but not all food establishments in the City, it excludes other beverages that have significantly higher concentrations of sugar sweeteners and/or calories on suspect grounds, and the loopholes inherent in the Rule, including but not limited to no limitations on re-fills, defeat and/or serve to gut the purpose of the Rule. For the aforementioned reasons, in the Article 78 branch of this action, The Portion Cap Rule is found to be arbitrary and capricious."

The Rest of the Story

The first key point in the decision is that the Department of Health and Mental Hygiene went beyond "regulating" and engaged in the process of "legislating." In other words, it made decisions not based purely on public health, but on economic and political concerns. Specifically, according to Tingling, it exempted convenience stores like 7-Eleven and Store 24 based on political, rather than health considerations. As I pointed out in my original post, there is no health justification for allowing a 7-Eleven to sell a 56-ounce Super Gigantic Gulp, while disallowing the cafe located right next door from selling an 18-ounce Moderate Gulp. Similarly, it makes no sense to ban monster sodas in delis if in those
same restaurants, a person can order a humongous milk shake.

The second key point in the decision is that the regulation was arbitrary and capricious, meaning that there is no rational basis for its differential treatment of different types of beverages and different types of food establishments. For example, two establishments might be next door to each other but be treated differently in terms of what they can or cannot sell. I would add that even within a single establishment, one type of sugar-laden beverage could be served in large sizes while another might not. Moreover, the net effect of this arbitrary differential treatment is to gut the benefits of the regulation.

There is a direct analogy here to tobacco control. The only smoking bans that have been struck down by the courts are those which grant arbitrary exemptions to certain types of establishments based on political or economic concerns, rather than public health concerns. For example, a Rhode Island Superior Court struck down certain exemptions in a state smoking ban that treated similar establishments differentially based on arbitrary factors such as the number of employees and whether they sell pre-cooked or freshly cooked sausages.

The rest of the story is that very often, the law is not the enemy of public health protection (as some are treating it in the wake of this decision) but actually the friends of public health protection. By ensuring that decisions are based on health concerns, rather than purely economic or political ones, and by discouraging arbitrary and capricious differential treatment of similar establishments absent any rational basis, the law is a force that may help public health agencies and groups to craft policies that will actually be more effective in achieving their goals.

Wednesday, March 13, 2013

Yesterday, I revealed that the University of Wisconsin Center for Tobacco Research and Intervention (UW-CTRI) is hiding its own conflict of interest with Big Pharma as well as that of its director on its page where it recommends the use of Chantix for smoking cessation. Today, I reveal that the Center is hiding its funding conflicts throughout its website and even in its annual reports.

Most of the individual web pages, including the home page, on the UW-CTRI site fail to disclose its support from Big Pharma and fail to identify the specific pharmaceutical companies supporting the Center. Only if you read the fine print - that is, a separate disclosure page, does the reader find out about the pharmaceutical funding. This is problematic, however, because most readers - especially members of the general public - are not going to specifically search for this disclosure.

Even on its funding page, the financial support from pharmaceutical companies is not acknowledged. The Big Pharma support is hidden within more general categories.

In its 20th anniversary annual report, covering the years 1992 to 2012, there is no disclosure of Big Pharma funding. On the last page of the report, a number of funders are listed, but no pharmaceutical company is mentioned.

In its 2008 annual report, the Center does acknowledge pharmaceutical funding. However, the name(s) of the companies are not disclosed. Nevertheless, in one of the articles listed in the report, a researcher with the Center disclosed that he: "has received research support from Pfizer, Nabi Biopharmaceutical, and Sanofi-Aventis and consulting fees from Nabi Biopharmaceutical."

In its 2006 annual report, the Center also acknowledges pharmaceutical funding but it again fails to disclose the name(s) of the companies from which it received funding.

The Rest of the Story

Unfortunately, UW-CTRI has not been transparent in disclosing its funding by pharmaceutical companies or the financial conflicts of interest of its individual faculty members. It took me extensive research of my own to piece together these conflicts of interest and required me to examine outside web sites (including original research articles that are not publicly available). Clearly, members of the public cannot or are not going to do this extensive research. In essence, then, UW-CTRI is hiding these important conflicts of interest from the public.

Of course, the most significant failed disclosure in my opinion is the medication page, where Chantix is promoted without any disclosure of the fact that the Center received funding from Pfizer to conduct clinical trials of Chantix and that the Center director previously had a personal financial interest in the company. Given the thousands of reports of suicides and other violent behavior in patients taking Chantix - reports that have not yet been sufficiently evaluated - I find this failed disclosure to be unacceptable.

If there were 2,700 filed in the U.S. against electronic cigarette manufacturers for alleged severe consequences including suicide and attempted suicide, e-cigs wouldn't remain on the market for 24 hours. Even the possibility that e-cigs may have caused 2,700 deaths would be enough to force these products off the market.

Yet despite the more than 3,000 lawsuits filed against Pfizer for alleged fatal or near fatal consequences of its smoking cessation drug Chantix, anti-smoking groups continue to recommend this drug for widespread use.

Even worse, the anti-smoking groups are encouraging the use of Chantix in the absence of any definitive studies to determine whether these thousands of deaths were indeed attributable to Chantix.

According to an article at Thomson Reuters, Pfizer has agreed to settle 2,700 lawsuits related to fatal or near-fatal consequences of Chantix, meaning that there will be no further discovery in these cases, and we will come no closer to understanding the potential role of Chantix in these tragedies.

According to the article: "The United States' largest drugmaker has entered into
agreements to settle around 80 percent of the more than 2,700
lawsuits over Chantix, costing the company around $273 million
in 2012, according to the report filed on Feb. 28. Pfizer also
said it has set aside $15 million to resolve all of the
remaining claims in the United States."

The Rest of the Story

It's difficult to understand the logic of anti-smoking groups. They are promoting Chantix, which has been alleged to cause more than 3,000 deaths. At the same time, they supported a ban on electronic cigarettes, which have been alleged to cause zero deaths.

What makes matters worse - and in my view, unacceptable - is that in a number of cases, anti-smoking advocates or groups that continue to push Chantix are failing to prominently disclose their financial conflicts of interest. These groups have taken money from Pfizer, creating a severe conflict of interest, yet they hide or obscure this information.For example, here is the page where the University of Wisconsin Center for Tobacco Research and Intervention (UW-CTRI) recommends the use of Chantix. Nothing on this page discloses that the Center or any of its faculty members have a conflict of interest by virtue of having taken money from Pfizer.However, in a 2008 article in JAMA, the Center's director made this disclosure: "In the past 5 years, Dr Fiore reports that he has lectured and consulted for Pfizer and has served as an investigator on research studies at the University of Wisconsin (UW) that were supported by GlaxoSmithKline, Nabi, Pfizer, and sanofi-aventis."So we find out that not only did the Center take money from Pfizer, but its director had a personal financial conflict of interest by having consulted for Pfizer. None of this is disclosed on the page where the Center recommends the use of Chantix, despite the more than 3,000 lawsuits filed against Pfizer for fatal or near-fatal alleged adverse events related to the drug.There is certainly room for disagreement about the role of Chantix compared to electronic cigarettes in smoking cessation (and my own opinion is that NRT, other smoking cessation drugs, and electronic cigarettes all play an important role). However, when public opinions are offered about drugs in an effort to promote the use of the drugs, then any financial conflicts of interest must be disclosed. I do not believe that UW-CTRI is adhering to this basic ethical principle.

Monday, March 11, 2013

A new study of the chemical constituents of the vapor produced by 12 brands of electronic cigarettes reports that these products greatly reduce exposure to the harmful chemicals in tobacco cigarettes and that e-cigarettes therefore show promise as a harm reduction strategy for tobacco control.

In the study, levels of selected carbonyl compounds, volatile organic compounds, tobacco-specific nitrosamines, and metals were analyzed in the vapor of 12 brands of electronic cigarettes and compared to levels of the same compounds in a medicinal nicotine inhaler and in regular tobacco cigarettes.

The results of the study were as follows: "levels of selected toxic compounds found in the smoke from a conventional cigarette were 9-450-fold higher than levels in the vapour of an e-cigarette. ... Smoking an e-cigarette (also referred to as 'vaping') can result in exposure to carcinogenic formaldehyde comparable with that received from cigarette smoking. Formaldehyde was also found in the vapour of medicinal inhalators, at levels that overlapped with those found in e-cigarette vapour. Exposure to acrolein, an oxidant and respiratory irritant thought to be a major contributor to cardiovascular disease from smoking, is 15 times lower on average in e-cigarette vapour compared with cigarette smoke. The amounts of toxic metals and aldehydes in e-cigarettes are trace amounts and are comparable with amounts contained in an examined therapeutic product."

The abstract concludes as follows: "Our findings are consistent with the idea that substituting tobacco
cigarettes with e-cigarettes may substantially reduce
exposure to selected
tobacco-specific toxicants. E-cigarettes as a harm reduction strategy
among smokers unwilling to quit,
warrants further study."

With regard to the safety of electronic cigarettes compared to real ones, the study concludes: "The results of this study support the proposition that the vapour from e-cigarettes is less injurious than the smoke from cigarettes. Thus one would expect that if a person switched from conventional cigarettes to e-cigarettes the exposure to toxic chemicals and related adverse health effects would be reduced."

The Rest of the Story

In my opinion, this study provides strong confirmation that electronic cigarettes are much safer than regular cigarettes. At this point, the totality of the scientific evidence is sufficient to conclude that switching from tobacco cigarettes to electronic cigarettes will substantially reduce the health risks associated with smoking. The FDA should allow electronic cigarette companies to make this claim, since it is sufficiently substantiated by scientific studies of the components of electronic cigarette vapor.

It is also important to emphasize that while few electronic cigarette companies are claiming that vaping reduces the hazards associated with smoking, they would not be making a fraudulent, misleading, or unsubstantiated claim if they did make such a statement in their marketing.

Likewise, any anti-smoking advocate or group that continues to claim that there is not evidence that using e-cigarettes is substantially safer than smoking is either unaware of or ignoring the evidence, and possibly making a fraudulent statement themselves.

Note also that this is an independent study which was not funded by any electronic cigarette company. The two funding sources were the Ministry of Science and Higher Education of Poland and the National Institutes of Health.This adds objectivity and credibility to the work.

Although this study demonstrates that e-cigarettes are safer than tobacco cigarettes, it also refutes the idea that e-cigarettes are safe in an absolute sense. It appears that the main risk associated with vaping is the potential inhalation of formaldehyde. Formaldehyde may result from the heating of propylene glycol or the oxidation or hydrolysis of glycerin. Of interest, the levels of formaldehyde among the 12 brands of electronic cigarettes ranged from just 3.2 micrograms per 150 puffs (about the same as a nicotine inhaler) to 56.1 micrograms per 150 puffs. This presents an opportunity to examine the reasons for these significant differences and hopefully, to find ways to produce e-cigarette liquid that does not produce high levels of formaldehyde. This should be a research priority for the FDA

The other health concern related to e-cigarette use is the risks associated with long-term inhalation of propylene glycol. If an excipient can be found which allows vaporization of nicotine but avoids propylene glycol and limits the formation of carbonyl compounds such as formaldehyde, it will be a huge advance and may lead to the development of an electronic cigarette product that is not merely safer than smoking, but is essentially safe as well (comparable to a medicinal nicotine product). The development of such a product should also be a priority for the FDA's Center for Tobacco Products.

Friday, March 08, 2013

For years, the tobacco companies tried to convince their customers that rather significant changes in their products - such as removing the additives or heating, rather than burning the tobacco - would result in a safer cigarette. In response, the anti-smoking groups attacked the cigarette companies, accusing of defrauding the American people. Eventually, these actions on the part of the industry were used by the federal government as evidence in a RICO case against the companies.

For example, in response to R.J. Reynolds' contention that Winston cigarettes were less hazardous because they contained no additives, the Campaign for Tobacco-Free Kids wrote: "RJR’s new ad campaign for its Winston brand takes an absurd and
deceptive approach, implying that erits new additive-free cigarettes are
healthier and somehow better for consumers."

And in response to the introduction of Philip Morris' Accord cigarettes, which involved heating rather than burning of tobacco, anti-smoking groups accused the company of deceiving the public by even suggesting that the product might be safer than traditional cigarettes. This despite clear evidence that levels of carcinogens in the emissions from Accord were drastically reduced.

Now, as Jacob Grier reported earlier this week in The Atlantic, the FDA is defending its failure to approve any of the more than 3500 substantial equivalence applications pending over the past 3 years by arguing that even minute changes to a cigarette's additives or design can make a cigarette significantly safer.

According to the article, the FDA defended its failure to approve any of the 3500 applications by arguing that "minor differences in composition or design could make cigarettes
significantly more dangerous or addictive."

The Rest of the Story

Not only is the FDA spouting old tobacco industry propaganda for which the anti-smoking groups and federal government attacked the companies, but it is taking that deception of the American public to an even higher level. While the cigarette companies merely suggested that major changes in their products could make a cigarette safer, the FDA is stating that miniscule changes in a cigarette can make it safer than others on the market.

The ultimate irony here is that if the cigarette companies made precisely the same claim as the FDA, the agency and anti-smoking groups would be blasting the companies and probably would be preparing a lawsuit against them for racketeering and fraud.

Not only is this propaganda deceptive but it is damaging to the public's appreciation of the hazards of cigarettes. Moreover, it contradicts and undermines the FDA's own statement that: "To date, no tobacco products have been scientifically proven to
reduce risk of tobacco-related disease, or cause less
harm than other tobacco products."

So here, on its web site, the FDA is going so far as asserting that even different classes of tobacco products - such as cigarettes, smokeless tobacco, and dissolvable tobacco - confer exactly the same risk.How can the FDA argue, on the one hand, that different classes of tobacco products confer no differences in health risk but at the same time, argue that even miniscule differences in cigarettes have major implications for health risk?

The answer is simple: the Center for Tobacco Products is not operating as a science-based agency. So far, it is operating on politics, rather than science.

Thursday, March 07, 2013

A study published yesterday in the journal Addiction Science & Clinical Practice reports the results of focus groups with electronic cigarette users and identifies five key features of these products that helps make them effective for smoking cessation among some smokers.

The study involved focus groups with 11 electronic cigarette users who were recruited through an ad placed on electronic cigarette internet forums. Ten of the 11 subjects had completely quit smoking using the electronic cigarette. The aim of the study was "to gain qualitative insight into whether e-cigarettes were
effective aids in long-term smoking cessation and why this might be the case, in addition to gaining a greater understanding of their efficacy on reducing cravings and preventing smoking relapse."

The main results were as follows:

"Five main themes were identified that explain why e-cigarettes appear, at least anecdotally, to be efficacious in helping tobacco users quit smoking."

4. Personal identity: "The majority of participants identified themselves as “vapers.” Previously they had defined themselves as “smokers,” and the e-cigarette allowed them to redefine their identity."

5. Difference between smoking cessation and nicotine cessation: "E-cigarettes allowed them to quit smoking, but some participants did not want to quit nicotine, because they enjoy the e-cigarette experience and viewed it as going from a dangerous form of nicotine intake in cigarettes to a safer form in e-cigarettes."

The Rest of the Story

The study concludes as follows:

"Results from these focus groups add to the albeit still limited research base regarding e-cigarettes and their usefulness as smoking cessation tools. The information gained provides new insights into the social and group dynamics that may underlie the reasons why NRT has such low observed rates of effectiveness, and why e-cigarettes, at least anecdotally, appear to be more effective for many vapers. Most notably, these include e-cigarettes becoming part of the vaper’s social identity, the recognition of vaping as a hobby, and the ability of these devices to aid in smoking cessation without complete nicotine cessation."

"These insights suggest that health practitioners should pay increased attention to the behavioral and social components of smoking addiction, many of which are not addressed by conventional NRTs, as noted by participants in this study. Greater understanding of these components could lead to more effective approaches to treating cigarette addiction, as the e-cigarette users in our focus groups experienced alleviation of withdrawal symptoms and achieved smoking cessation more effectively than they had with conventional NRT."

Wednesday, March 06, 2013

While the FDA and anti-smoking groups continue to devote their attention to the non-existent problem of electronic cigarette use among youth, the agency's lack of action on menthol is leading to increased smoking among the nation's youth. According to an article at the Business Insider, Camel's market share among 12-17 year-old youth has increased by 21%, a jump to attributable to Camel Crush, a menthol cigarette variety that contains a capsule that when crushed, releases menthol.

According to the article: " investors might want to consider Camel, which has increased its
market share among 12-17 year olds by 21 percent—a gain attributed to
the Camel Crush cigarette which switches from plain to menthol when you
squeeze it. And, of course, kids love Joe Camel. Newport is also gaining ground among young people. ... Kids tend toward premium cigarettes because they smoke less, and they have a strong and growing preference for menthol."

Despite the growing preference for menthol, the FDA has so far punted on the opportunity to eliminate menthol cigarettes. At the same time, while few if any kids are using electronic cigarettes, the FDA has made every attempt to ban or discourage the use of these products.

The Rest of the Story

This is a case of misplaced priorities:

Researchers are having trouble finding a single nonsmoking youth who uses electronic cigarettes, yet the FDA is doing everything it can to get these products off the market.

Evidence mounts that menthol cigarette use is skyrocketing among youth and the FDA sits on its hands and does nothing to combat the problem.

There is also new evidence that menthol cigarettes serve as a starter product for youth. The lead investigator of that study stated: "We know from national surveys that the youngest smokers
disproportionately use menthol cigarettes. Since our study followed a
cohort of the same individuals over time, we have also been able to show
that young smokers are more likely to switch from menthol to nonmenthol
cigarettes early in their smoking careers, providing further evidence
that menthols serve as a starter product for young smokers."

Unfortunately, the FDA has so far demonstrated mixed-up priorities: the agency has focused on the problems least relevant to protecting the public's health, such as electronic cigarettes, dissolvable tobacco products, and monitoring substantial equivalence claims, yet has ignored the most relevant problems: real cigarettes, and especially the menthol ones.

Tuesday, March 05, 2013

There is a great irony in the way that the FDA and anti-smoking groups are treating electronic cigarettes.

On the one hand, the FDA and anti-smoking groups are warning us that because these products are marketed as alternatives to cigarette smoking, they may appeal to youth or adult nonsmokers and eventually lead to cigarette smoking initiation.

On the other hand, the FDA and anti-smoking groups are telling us that these products cannot be marketed for smoking cessation because the agency would treat that as a drug claim and take the product off the market under the provisions of the Food, Drug, and Cosmetic Act.

The Rest of the Story

In fact, the greatest threat that could lead nonsmokers to try electronic cigarettes comes not from the electronic cigarette companies, but from the FDA, CDC, and anti-smoking groups.

If the electronic cigarette companies had their way, they would market their products as devices for smoking cessation or smoking reduction. The only reason they are not doing this is the stated threat from the FDA to take their products off the market if they make smoking cessation claims. So instead of telling their consumers the truth - that these products are intended for smoking cessation/reduction - they are forced to essentially lie to the public and market them solely as an "alternative" to cigarettes.

But the great irony is that if electronic cigarettes were marketed as a smoking cessation or reduction device, then the potential threat that they would lead to smoking initiation among nonsmokers would be minimized. It is only because these companies are forced to market their products as an "alternative" to cigarette smoking that any potential appeal for the use of these products among nonsmokers remains.

So the irony is that by disallowing smoking cessation claims and forcing the electronic cigarette companies to instead market their products as "smoking alternatives," the FDA and anti-smoking groups are:

1. Essentially forcing the electronic cigarette companes to lie about the real purpose of these products;

2. Forcing the electronic cigarette companies not to be transparent with their customers and to deceive them about the real advantages of the product; and

3. Maximizing the possibility that nonsmokers may try these products, rather than minimizing it.

The most prudent public health approach would be for the FDA to explicitly allow electronic cigarette companies to tell the truth and to inform the consumer that the primary intended purpose of these products is to help smokers reduce or eliminate tobacco cigarette use, which will reduce their risk of disease. As I have explained, such a claim would not be a drug claim because smoking is a behavior, not a disease.

The rest of the story is that in their obsession over preventing electronic cigarette companies from truthfully telling their consumers that these products may be useful for, and are intended for, smoking reduction and cessation, the FDA and the anti-smoking groups are doing more harm than good. They are forcing the companies to lie to the public, maximizing the chances that nonsmokers may try these products, and inhibiting smokers from quitting.

Monday, March 04, 2013

According to a national survey conducted by the Centers for Disease Control and Prevention (CDC), there was a tremendous increase in electronic cigarette use among smokers from 2010 to 2011 along with a large increase in the proportion of former smokers who reported having used electronic cigarettes, but without any increase in use by never smokers, suggesting that these products show promise as part of a national strategy for smoking cessation and reduction.

The study reported that ever use of electronic cigarettes among smokers increased from 9.8% in 2010 to 21.2% in 2011. Ever use of electronic cigarettes among former smokers increased from 2.5% to 7.4%. Ever use among never smokers remained steady at 1.3%.

In a press release accompanying the article, CDC Director Tom Frieden, MD, MPH, stated: "E-cigarette use is growing rapidly. There is still a lot we don’t know about these products, including
whether they will decrease or increase use of traditional cigarettes."

Also in the press release, director of the Office on Smoking and Health at CDC - Dr. Tim McAfee - stated: "If large numbers of adult smokers become users of both traditional
cigarettes and e-cigarettes — rather than using e-cigarettes to quit
cigarettes completely — the net public health effect could be quite
negative."

The Rest of the Story

Despite the CDC's concerns about the use of electronic cigarettes among youth to cigarette smoking initiation, there is no evidence that such a phenomenon is occurring. This study shows that despite the tremendous growth in awareness, publicity, and marketing of electronic cigarettes, there has been no recent increase in the ever use of these products among adult nonsmokers.

The study also demonstrates a tremendous increase in ever use of electronic cigarettes among smokers. Furthermore, it demonstrates that a large proportion of former smokers have used electronic cigarettes. This doesn't prove that they used the electronic cigarettes successfully to achieve cessation, but it is consistent with this hypothesis.

Combined, these results add further support to the evidence that electronic cigarettes are a promising strategy to enhance smoking cessation and smoking reduction.

Interestingly, despite what these results actually suggest, the CDC is presenting them in a most negative light. The CDC director emphasizes that we don't know whether the use of electronic cigarettes will increase or decrease the use of traditional cigarettes. However, there are only two ways electronic cigarettes could increase the use of traditional cigarettes: (1) if smokers who would otherwise have quit switch to electronic cigarette and tobacco cigarette dual use; or (2) if nonsmokers begin using electronic cigarettes and then initiate cigarette smoking.

There is absolutely no evidence that #2 is occurring. Electronic cigarettes are not popular among youth nonsmokers and in prior surveys, it has been difficult to identify even a single youth nonsmoker who uses electronic cigarettes.

There is also no evidence that #1 is occurring. Most electronic cigarette users are attracted to these products because they want to cut down or quit smoking but have failed to do so using other available smoking cessation products, like drugs. It is unlikely that these smokers would have quit smoking completely had it not been for electronic cigarettes.

The director of the Office on Smoking and Health is incorrect in stating that: "If large numbers of adult smokers become users of both traditional
cigarettes and e-cigarettes — rather than using e-cigarettes to quit
cigarettes completely — the net public health effect could be quite
negative."

Actually, the net public health effect could only be negative if large numbers of adult smokers who would otherwise have quit smoking completely become dual users of traditional cigarettes and e-cigarettes. If large numbers of adult smokers who would not have quit smoking completely reduce their cigarette consumption by substituting electronic cigarettes for some of their tobacco cigarettes, then the net effect on public health will be massively positive, as there would be a substantial decline in cigarette consumption.

About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 32 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.